Diph

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

Fd&c Blue No. 1 Anhydrous Lactose Starch, Corn Gelatin D&c Red No. 28 Fd&c Red No. 40

Identifiers & Packaging

Pill Appearance

Imprint: cpc;835 Shape: capsule Color: pink Size: 14 mm Score: 1

Marketing Status

OTC MONOGRAPH FINAL Active Since 2018-01-01

Medication Information

Warnings and Precautions

Do not use

25 MG

to make a child sleepy

with any other product containing diphenhydramine, even one used on skin

50 MG

to make a child sleepy

with any other product containing diphenhydramine, including one applied topically

Purpose

Antihistamine

Description

Diphenhydramine HCl… 25 mg Diphenhydramine HCl… 50 mg

Use

25 MG

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose

sneezing

itchy, watery eyes

itchy throat and nose

Temporarily relieves these symptoms due to the common cold:

runny nose

sneezing

50 MG

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold

sneezing

runny nose

itchy, watery eyes

itchy throat and nose

Directions

Take every 4-6 hours

Do not take more than 6 doses in 24 hours

25 MG

adults and children 12 years of age and over 1 to 2 capsules

children 6 years to under 12 years of age 1 capsule

children under 6 years of age do not use this product in children under 6 years of age

50 MG

adults and children 12 years of age and over 1 capsule

children 6 years to under 12 years of age Ask a doctor, the proper dosage strength is not available in this package**

**Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package.

Questions?

Questions or comments? (800) 616-2471

Distributed By

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233,

Livonia, MI 48152

Other Information

Store at 20°C – 25°C (68°F – 77°F); excursions permitted to 15° – 30°C (59° – 86°F) [See USP Controlled Room Temperature]

Protect from moisture

Contains lactose

Inactive Ingredients

D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch.

When Using This Product

marked drowsiness may occur

avoid alcoholic drinks

alcohol, sedatives, and tranquilizers may increase drowsiness

be careful when driving a motor vehicle or operating machinery

excitability may occur, especially in children

Ask A Doctor Or Pharmacist

before use if you are taking sedatives or tranquilizers

If Pregnant Or Breast Feeding

ask a health professional before use.

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have

25 MG

a breathing problem such as emphysema or chronic bronchitis

glaucoma

trouble urinating due to an enlarged prostate gland

50 MG

glaucoma

a breathing problem such as emphysema or chronic bronchitis

difficulty in urination due to enlargement of the prostate gland

Package Label.principal Display Panel

Active Ingredient (in Each Banded Capsule)

Diphenhydramine HCl… 25 mg

Diphenhydramine HCl… 50 mg

Structured Label Content

Use (USE)

25 MG

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose

sneezing

itchy, watery eyes

itchy throat and nose

Temporarily relieves these symptoms due to the common cold:

runny nose

sneezing

50 MG

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold

sneezing

runny nose

itchy, watery eyes

itchy throat and nose

Warnings and Precautions (34071-1)

Do not use

25 MG

to make a child sleepy

with any other product containing diphenhydramine, even one used on skin

50 MG

to make a child sleepy

with any other product containing diphenhydramine, including one applied topically

Purpose (PURPOSE)

Antihistamine

Directions (DIRECTIONS)

Take every 4-6 hours

Do not take more than 6 doses in 24 hours

25 MG

adults and children 12 years of age and over 1 to 2 capsules

children 6 years to under 12 years of age 1 capsule

children under 6 years of age do not use this product in children under 6 years of age

50 MG

adults and children 12 years of age and over 1 capsule

children 6 years to under 12 years of age Ask a doctor, the proper dosage strength is not available in this package**

**Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package.

Questions? (QUESTIONS?)

Questions or comments? (800) 616-2471

Distributed By (DISTRIBUTED BY)

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233,

Livonia, MI 48152

Other Information (OTHER INFORMATION)

Store at 20°C – 25°C (68°F – 77°F); excursions permitted to 15° – 30°C (59° – 86°F) [See USP Controlled Room Temperature]

Protect from moisture

Contains lactose

Inactive Ingredients (INACTIVE INGREDIENTS)

D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch.

When Using This Product (WHEN USING THIS PRODUCT)

marked drowsiness may occur

avoid alcoholic drinks

alcohol, sedatives, and tranquilizers may increase drowsiness

be careful when driving a motor vehicle or operating machinery

excitability may occur, especially in children

Ask A Doctor Or Pharmacist (ASK A DOCTOR OR PHARMACIST)

before use if you are taking sedatives or tranquilizers

If Pregnant Or Breast Feeding (IF PREGNANT OR BREAST-FEEDING)

ask a health professional before use.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (ASK A DOCTOR BEFORE USE IF YOU HAVE)

25 MG

a breathing problem such as emphysema or chronic bronchitis

glaucoma

trouble urinating due to an enlarged prostate gland

50 MG

glaucoma

a breathing problem such as emphysema or chronic bronchitis

difficulty in urination due to enlargement of the prostate gland

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Active Ingredient (in Each Banded Capsule) (ACTIVE INGREDIENT (IN EACH BANDED CAPSULE))

Diphenhydramine HCl… 25 mg

Diphenhydramine HCl… 50 mg

Advanced Ingredient Data

[{"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS LACTOSE", "unii": "3SY5LH9PMK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 28", "unii": "767IP0Y5NH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USE": "25 MG Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itchy throat and nose Temporarily relieves these symptoms due to the common cold: runny nose sneezing 50 MG Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold sneezing runny nose itchy, watery eyes itchy throat and nose", "34071-1": "Do not use 25 MG to make a child sleepy with any other product containing diphenhydramine, even one used on skin 50 MG to make a child sleepy with any other product containing diphenhydramine, including one applied topically", "PURPOSE": "Antihistamine", "DIRECTIONS": "Take every 4-6 hours Do not take more than 6 doses in 24 hours 25 MG adults and children 12 years of age and over 1 to 2 capsules children 6 years to under 12 years of age 1 capsule children under 6 years of age do not use this product in children under 6 years of age 50 MG adults and children 12 years of age and over 1 capsule children 6 years to under 12 years of age Ask a doctor, the proper dosage strength is not available in this package** **Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package.", "QUESTIONS?": "Questions or comments? (800) 616-2471", "DISTRIBUTED BY": "MAJOR® PHARMACEUTICALS 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152", "OTHER INFORMATION": "Store at 20°C – 25°C (68°F – 77°F); excursions permitted to 15° – 30°C (59° – 86°F) [See USP Controlled Room Temperature] Protect from moisture Contains lactose", "INACTIVE INGREDIENTS": "D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch.", "WHEN USING THIS PRODUCT": "marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children", "ASK A DOCTOR OR PHARMACIST": "before use if you are taking sedatives or tranquilizers", "IF PREGNANT OR BREAST-FEEDING": "ask a health professional before use.", "KEEP OUT OF REACH OF CHILDREN": "In case of overdose, get medical help or contact a Poison Control Center right away.", "ASK A DOCTOR BEFORE USE IF YOU HAVE": "25 MG a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland 50 MG glaucoma a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland", "ACTIVE INGREDIENT (IN EACH BANDED CAPSULE)": "Diphenhydramine HCl… 25 mg Diphenhydramine HCl… 50 mg"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information